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Peripheral Retina Robotically Aligned OCT Study

NCT06451068 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-04-13

No results posted yet for this study

Summary

Optical coherence tomography (OCT) is a 3D imaging technology that has seen wide adoption within ophthalmology. However, optical access to the retinal periphery remains a challenge for conventional OCT systems. The study team plans to innovate peripheral retinal OCT imaging technology by first developing the first robotic OCT system capable of autonomously assisting the operator during imaging of the human peripheral retina using 3D active tracking and compensation and then by developing of the first OCT system designed for treatment of the retinal periphery.

Conditions

  • Retinal Disease

Interventions

DEVICE

Peripheral retina robotically aligned optical coherence tomography (OCT) system

To visualize the full 360° of the retinal periphery (from equator to the more anterior ora serrata), investigators developed and redesigned a conical mirror contact lens and our non-contact robotically aligning platform to deliver OCT to the peripheral retina. The peripheral retina robotically aligned OCT (PR-RAOCT) system is built around a 6-axis cooperative robot (UR5e, Universal Robots), using our previously developed RAOCT control software.

OTHER

Likert Scales

Survey evaluating relative comfort with each type of peripheral exam (scleral depression vs. PR-RAOCT). Participants will rate 3 items on a 1 (non) to 5 (maximum) Likert scale: overall discomfort, physical pain, and photophobia for each exam.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Eye Institute (NEI)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Cynthia A Toth, MD · Duke University Eye Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06451068 on ClinicalTrials.gov